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GUIDANCE DOCUMENT

E17 General Principles for Planning and Design of Multi-Regional Clinical Trials July 2018

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
2018-15395
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

With the increasing globalization of drug development, it has become important that data from multiregional clinical trials (MRCTs) can be accepted by regulatory authorities across regions and countries as the primary source of evidence to support marketing approval of drugs (medicinal products). The purpose of this guidance is to describe general principles for the planning and design of MRCTs with the aim of increasing the acceptability of MRCTs in global regulatory submissions. 
 

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